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Thyroid Function & Breast Cancer: A Pilot Study to Estimate the Prevalence of Thyroid Dysfunction in Women Diagnosed With Breast Cancer and the Magnitude of Change in Thyroid Function Post-Chemotherapy

Brief Summary

RATIONALE: Learning about thyroid dysfunction in patients with breast cancer may help plan treatment and may help patients live more comfortably.

PURPOSE: This clinical trial is studying how often thyroid dysfunction happens in women with newly diagnosed stage I, stage II, or stage III breast cancer who are planning to undergo chemotherapy compared to how often it happens in healthy volunteers.

Patients and age-matched healthy volunteers undergo blood collection at baseline and at 12 and 24 months after enrollment. They also undergo anthropometric measurements and complete the Fatigue Symptom Inventory at baseline and at 12 and 24 months after enrollment.

PROJECTED ACCRUAL: A total of 270 patients and 280 healthy volunteers will be accrued for this study.

Study Type

Observational

Study Design

Observational Model: Case ControlTime Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

Markers of thyroid function including thyroid stimulating hormone (TSH), Free thyroxine (free T4) and Thyroid peroxidase antibody (TPO Ab). These will be performed at baseline, in 12 months and again 24 months after enrollment. All thyroid function marker assays will be performed by LabCorp.

Sampling Method

Non-Probability Sample

Study Population

This is a pilot study with a planned accrual of 270 patients (cases) and 280 healthy volunteers (controls). Patients between the ages of 25 and 75, diagnosed with primary, operable, stage I-III B breast cancer with planned chemotherapy regimen Adriamycin / Cytoxan (AC) plus a taxane are trial candidates. Participants will be asked to nominate 2 women to serve as their healthy control. In the event the first woman is not eligible or decides not to participate, the second woman will be evaluated. Controls will be women from the same general demographic area, have no prior history of cancer and be within 5 years of the patient's age (+/- 5 years).

Condition

Breast Cancer

Fatigue

Hypothyroidism

Intervention

Other: physiologic testing

Markers of thyroid function including thyroid stimulating hormone (TSH), Free thyroxine (free T4) and Thyroid peroxidase antibody (TPO Ab). These will be performed at baseline, in 12 months and again 24 months after enrollment. All thyroid function marker assays will be performed by LabCorp.

Other Name: thyroid function tests

Procedure: fatigue assessment and management

Fatigue Symptoms Inventory (FSI) survey

Other Names:

FSI

Fatigue Symptoms Inventory

Procedure: management of therapy complications

If baseline testing results suggest hyperthyroidism or hypothyroidism, the enrolling center will give test results to participants for follow-up with their primary healthcare provider. Participants with hypothyroidism, who are not started on thyroid hormone, will continue on study, given the TSH level is below 10. Those with hypothyroidism who have treatment initiated will not continue on study. Participants who develop hypothyroidism during the study will not continue on-study if replacement therapy is initiated or if the TSH level is 10 or higher. Work up the next control nominated by the patient or contact the patient for the name of another control

Will have physiologic testing at baseline to assess thyroid function and fatigue assessment and management inventory. Will follow-up on management of therapy complications for thyroid disorder if one identified or until off study.

Interventions:

Other: physiologic testing

Procedure: fatigue assessment and management

Procedure: management of therapy complications

Group 2 Healthy Controls

Controls will be women from the same general demographic area as Group 1 Cases, have no prior history of cancer and be within 5 years of the Group 1 case's age (+/- 5 years).

Will have physiologic testing at baseline to assess thyroid function and fatigue assessment and management inventory. Will follow-up on management of therapy complications for thyroid disorder if one identified or until off study.

Interventions:

Other: physiologic testing

Procedure: fatigue assessment and management

Procedure: management of therapy complications

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Completed

Enrollment

541

Completion Date

June 2015

Primary Completion Date

June 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

CASE SELECTION:

CASE INCLUSION CRITERIA:

Women between the ages of 25 and 75

Diagnosed with primary and operable Stage I - IIIB breast cancer

Scheduled to receive neoadjuvant or adjuvant Adriamycin and Cytoxan (AC) plus a taxane (taxane may be given with AC or follow AC)

Received adjuvant hormonal therapy or chemotherapy prior to sample collection

On chemotherapeutic regimen other than Adriamycin and Cytoxan plus a taxane.

Patients receiving monoclonal antibodies or other biologic therapy may not participate

Patients scheduled to receive Herceptin may not participate

Diagnosed with hyperthyroidism or hypothyroidism. (Women being treated for hypothyroidism are not eligible)

Women with a baseline TSH of 10 or higher will not continue on study

Women who are pregnant or lactating are not eligible. (Women of childbearing potential who are planning to become pregnant within the next 24 months should not enroll in this study)

CONTROL SELECTION:

CONTROL INCLUSION CRITERIA:

Cannot be a blood relative of the case. They can be friends, neighbors, women from social activities, local business, doctors' offices, etc.

Must live near or in the town of the case

Women between the ages of 20 and 80 (age-matched to cases +/- 5 years)

No prior history of cancer (except non-melanoma skin cancer)

Women ages 40 and older should have had a mammogram within 2 years of study entry, showing no evidence of breast cancer.

The friend control may bring their mammogram report or send a release and have records faxed to the enrolling center.

Women under the age of 40 should have had a clinical breast examination within 2 years of study entry, showing no need for diagnostic mammography. If a mammogram was required, it should show no evidence of breast cancer.

The friend control may bring their mammogram / breast exam report or send a release and have records faxed to the enrolling center.

Sex/Gender

Sexes Eligible for Study:

Female

Ages

20 Years to 80 Years (Adult, Senior)

Accepts Healthy Volunteers

Yes

Contacts

Contact information is only displayed when the study is recruiting subjects